Ensuring that packaging maintains its protective role without any leaks or failures is essential for product safety and quality. Traditional methods, such as Vacuum Bubble and Dye Penetration tests, have long been used to assess the integrity of sealed packages. Advancements in testing technologies have led to the development of more sophisticated methods like SIMS 1915+, which offers enhanced sensitivity and reliability compared to these conventional techniques.
Traditional package integrity tests
Traditional package integrity tests are commonly used in the packaging industry to ensure that products, especially sterile or sensitive ones, are protected during transportation and storage. The traditional tests include:
- Vacuum Bubble Test:
This test involves submerging the package in a liquid (often water) and applying a vacuum. If there's a leak, air bubbles will form at the site of the breach, making it possible to visually detect the failure.
- Dye Penetration Test:
In this test, a dye (usually a coloured liquid) is applied to the package and then observed for signs of leakage. If there is a flaw or hole in the package, the dye will penetrate through it, and this is detected visually.
Helium Leak Testing using SIMS 1915+
Seal Integrity Monitoring System (SIMS) 1915+ is the perfect choice for a helium leak detection solution. Packages can be quantitatively evaluated to levels significantly higher than the vacuum bubble and dye penetration test procedures when helium is used as the tracer gas. By offering direct comparison over a wide range of packing materials and kinds, production line settings, and stable storage conditions, this quantitative technique supports the full lifespan. Package design, tooling certification, manufacturing line setup, and ongoing product quality monitoring are all possible using SIMS 1915+. Every SIMS 1915+ helium leak testing apparatus is constructed in accordance with the requirements of the client. The sensitivity of the quantitative CCI assessments that SIMS 1915+ can perform on packages is as low as 1 x 10 -10 mbar L/s. SIMS 1915+ also offers a complete Data Integrity software package compliant with 21CFR Part 11 requirements.
Benefits of SIMS 1915+
- High Sensitivity: Detects leaks as small as 1 x 10^-10 mbar/L/sec, far surpassing traditional methods.
- Quantitative Leak Detection: Provides precise leak rate measurement for better quality control and analysis.
- Versatile and Comprehensive: Suitable for a wide range of packaging formats, including bottles, syringes, vials, and blister cards.
- Customization for Specific Needs: Tailored to customer specifications for packaging types and production environments.
- Enhanced Regulatory Compliance: Provides verifiable evidence of packaging integrity, ensuring compliance with industry regulations.
The SIMS 1915+ helium-based leak detection system represents a significant advancement in package integrity testing. With its high sensitivity, ability to perform quantitative leak detection, and compatibility with a wide range of packaging formats, SIMS 1915+ offers a more accurate, reliable, and efficient solution.
helium leak testing, helium leak detection, pharmaceutical packaging
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